MAUDE Adverse Event Report: MAKO SURGICAL CORP. HANDPIECE MICS; STEREOTACTIC DEVICE, ROBOTICS

Catalog Number 209063

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Temperature Problem (3022)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.

Event Description

Prior to a total hip arthroplasty procedure, the mics handpiece was very warm and was giving a temperature error when checking mics status check (due to it having to be one-trayed).After allowing the mics to cool longer about 25 minutes we rechecked the mics status check and got a green code.After opening the tha software a burr status mismatch call service error code occurred.The surgeon completed the case manually.

Manufacturer Narrative

Reported event: it was reported that a handpiece was not functioning.Issue was noticed prior to a case, there was a case delay and the case was completed manual.Device history review: review of the device history records indicate (b)(4) devices were manufactured under lot k0672 and (b)(4) including 4000316 were accepted into final stock on 11/12/2015." visual inspection: visual inspection revealed no physical damage of unit.Dimensional inspection: dimensional inspection was not completed.Reported problem was a functional issue.Functional inspection: the handpiece was tested in the handpiece test (qip0243) and passed.The motor spun as expected during the test.The cable was agitated during the test and the unit remained functional.Screenshot of passing test is attached.A review of complaints related to p/n 209063 shows the failure to operate in 19 other complaints was unable to be duplicated.These complaint investigations are: (b)(4).Issues for p/n 209063 will be completed through trend request #900.Conclusions: failure was not duplicated.The handpiece was tested in the handpiece test (qip0243) and passed.The motor spun as expected during the test.The cable was agitated during the test and the unit remained functional.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.".

Event Description

Prior to a total hip arthroplasty procedure, the mics handpiece was very warm and was giving a temperature error when checking mics status check (due to it having to be one-trayed).After allowing the mics to cool longer about 25 minutes we rechecked the mics status check and got a green code.After opening the tha software a burr status mismatch call service error code occurred.The surgeon completed the case manually.

• Brand Name: HANDPIECE MICS
• Type of Device: STEREOTACTIC DEVICE, ROBOTICS
• Manufacturer (Section D): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer (Section G): MAKO SURGICAL CORP.; 2555 davie road; fort lauderdale FL 33317
• Manufacturer Contact: michael mcavenia ; 2555 davie road; fort lauderdale, FL 33317 ; 9546280700
• MDR Report Key: 6145946
• MDR Text Key: 61465276
• Report Number: 3005985723-2016-00412
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141989
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 209063
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/05/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization